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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K925352
Device Name CLEAN CUFF BLOOD PRESSURE CUFF LINER
Applicant
Steridyne Corp.
3725 Investment Ln.
Riviera Beach,  FL  33404
Applicant Contact MARK P PONCY
Correspondent
Steridyne Corp.
3725 Investment Ln.
Riviera Beach,  FL  33404
Correspondent Contact MARK P PONCY
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received10/22/1992
Decision Date 01/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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